Hemophilia B Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

DelveInsight's, "Hemophilia B Pipeline Insight 2025" report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Hemophilia B pipeline landscape. It covers the Hemophilia B pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Hemophilia B pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Hemophilia B Pipeline Report

* On 03 September 2025, Pfizer announced a long-term safety and efficacy follow-up for individuals with Hemophilia B who were previously enrolled in the C0371005 (formerly SPK-9001-101) trial. In addition, the company is initiating a dose-escalation sub-study designed to evaluate the safety, tolerability, and kinetics of a higher dose, along with long-term safety and efficacy monitoring. Notably, participants in this sub-study are not required to have taken part in the original C0371005 trial.
* DelveInsight's Hemophilia B Pipeline report depicts a robust space with 15+ active players working to develop 20+ pipeline therapies for Hemophilia B treatment.
* The leading Hemophilia B Companies such as Shanghai Vitalgen BioPharma, Belief BioMed, TiumBio, Jiangsu Gensciences, Centessa Pharmaceuticals, Takeda, Sanofi, GC Biopharma Corp, Equilibra Bioscience LLC, Regeneron Pharmaceuticals, ISU Abxis and others.
* Promising Hemophilia B Therapies such as REGV131, LNP1265, APVO101, SPK-9001, ANB-002, Benefix, IB1001, marstacimab and others.

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Hemophilia B Emerging Drugs Profile

* BBM-H901: Belief Biomed

BBM-H901 is indicated for prophylactic treatment of bleeding in adults with hemophilia B. BBM-H901 is designed to restore the production of factor IX (FIX) the blood-clotting protein that is faulty or missing in people with hemophilia B by delivering a functional copy of the F9 gene to liver cells, which are the main producers of clotting factors in the body. Gene therapy components are delivered to liver cells by a modified, harmless adeno-associated virus (AAV) that works as a vehicle. The gene therapy is given as a single intravenous (into-the-vein) infusion. The drug BBM-H901 is in the Phase III clinical trial for the treatment of hemophilia B.

* ISU304: ISU ABXIS

ISU304 (Dalcinonacog alfa, DalcA) is a modified recombinant Factor IX protein for the prophylactic therapy of patients with Hemophilia B which is caused by a deficiency of coagulation FIX. It is designed to be administered subcutaneously and achieves normal FIX activity levels to prevent bleeding of patients with hemophilia B. Currently approved protein replacement therapy for hemophilia B rely on intravenous injection. With a subcutaneous injection, ISU304 is expected to improve the quality of life and treatment convenience in patients with hemophilia B. The drug is in phase II stage of its clinical trial for the treatment of hemophilia B.

* TU7710: TiumBio

TU7710 is a bypassing agent treatment for patients with neutralizing antibodies and is an innovative drug candidate with a half-life 6~7 times greater than conventional treatments through our transferrin fusion gene recombination technology. TU7710 is expected to dramatically improve the convenience and quality of life of hemophilia patients with neutralizing antibodies. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Hemophilia B.

The Hemophilia B Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Hemophilia B with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hemophilia B Treatment.
* Hemophilia B Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Hemophilia B Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hemophilia B market

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Hemophilia B Companies

Shanghai Vitalgen BioPharma, Belief BioMed, TiumBio, Jiangsu Gensciences, Centessa Pharmaceuticals, Takeda, Sanofi, GC Biopharma Corp, Equilibra Bioscience LLC, Regeneron Pharmaceuticals, ISU Abxis and others.

Hemophilia B pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

Hemophilia B Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

Learn about new Hemophilia B drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Hemophilia B Market Drivers and Barriers [https://www.delveinsight.com/sample-request/hemophilia-b-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Scope of the Hemophilia B Pipeline Report

* Coverage- Global
* Hemophilia B Companies- Shanghai Vitalgen BioPharma, Belief BioMed, TiumBio, Jiangsu Gensciences, Centessa Pharmaceuticals, Takeda, Sanofi, GC Biopharma Corp, Equilibra Bioscience LLC, Regeneron Pharmaceuticals, ISU Abxis and others.
* Hemophilia B Therapies- REGV131, LNP1265, APVO101, SPK-9001, ANB-002, Benefix, IB1001, marstacimab and others.
* Hemophilia B Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Hemophilia B Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Download DelveInsight's in-depth Hemophilia B Pipeline report today! @ Hemophilia B Companies, Key Products and Unmet Needs [https://www.delveinsight.com/sample-request/hemophilia-b-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Contents

* Introduction
* Executive Summary
* Hemophilia B: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Hemophilia B - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* BBM-H901: Belief Biomed
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* ISU304: ISU ABXIS
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* TU7710: TiumBio
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Hemophilia B Key Companies
* Hemophilia B Key Products
* Hemophilia B - Unmet Needs
* Hemophilia B - Market Drivers and Barriers
* Hemophilia B - Future Perspectives and Conclusion
* Hemophilia B Analyst Views
* Hemophilia B Key Companies
* Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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